A Study of Pentasa in Patients With Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01104753
First received: March 26, 2010
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).


Condition
Ulcerative Colitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Verify the safety profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • Number of AEs/SAEs
    • Intensity and seriousness of reported AEs/SAEs


Enrollment: 338
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-interventional post-authorisation safety study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from ulcerative colitis

Criteria

Inclusion Criteria:

  • Patients suffering from ulcerative colitis

Exclusion Criteria:

  • Hypersensitivity to mesalazine, salicylates or to any excipient
  • Severe damage to liver or renal functions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104753

Locations
Czech Republic
Hospital Brandýs n/Lab.
Brandys nad Labem, Czech Republic
Faculty Hospital U Sv. Anny Brno
Brno, Czech Republic
Hospital Břeclav
Břeclav, Czech Republic
Investigational site
Chomutov, Czech Republic
Hospital Chrudim
Chrudim, Czech Republic
Hospital. Frýdek- Místek
Frýdek- Místek, Czech Republic
Investigational site
Hodonín, Czech Republic
Investigational site
Hradec Králové, Czech Republic
Hospital Karviná
Karviná, Czech Republic
Investigational site
Litoměřice, Czech Republic
Hospitál Mladá Bolesl
Mladá Boleslav, Czech Republic
Faculty Hospital Olomouc
Olomouc, Czech Republic
Investigational site
Ostrava, Czech Republic
Vítkovická Hospital
Ostrava, Czech Republic
Gastromedic s.r.o.,ul.
Pardubice, Czech Republic
Faculty Hospital Bpry Plzeň
Plzeň, Czech Republic
Faculty Hospital Lochotín Plzeň
Plzeň, Czech Republic
NMSB, Praha 1
Praha, Czech Republic
Faculty Hospital Motol, Praha 5
Praha, Czech Republic
Thomayerova hospital., Praha 4
Praha, Czech Republic
ÚVN, Praha 6
Praha, Czech Republic
Poliklinika Prosek, Praha
Praha, Czech Republic
VFN, Praha 2
Praha, Czech Republic
Investigational site
Přerov, Czech Republic
Hospital Svitavy
Svitavy, Czech Republic
Provincial hospital, Kpt.
Tábor, Czech Republic
Hospital T. Bati Zlín
Zlín, Czech Republic
Hospital Znojmo
Znojmo, Czech Republic
Investigational site
Ústí n.Labem, Czech Republic
Investigational site
České Budějovice, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104753     History of Changes
Other Study ID Numbers: FE999907 CS07
Study First Received: March 26, 2010
Last Updated: April 6, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 16, 2014